The invention relates generally to a holder for an annuloplasty ring which consists in a plurality of linked-together suture platforms.
Modern ring annuloplasty techniques originate from Carpentier's original concept of “valvular remodeling on a frame” published in French in 1969 and in English in 1971 (Carpentier A, et al, A new reconstructive operation for correction of mitral and tricuspid insufficiency. J Thorac Cardiovasc Surg 1971; 61:1-13). His idea was to permanently correct the valvular insufficiency by resizing and reshaping the dilated annulus with a preformed rigid (“non-deformable”) ring affixed to the annulus with numerous interrupted horizontal mattress sutures.
In the interest of preserving the flexibility of the mitral annulus, Duran and Ubago (Duran C G, Ubago J L, Clinical and hemodynamic performance of a totally flexible prosthetic ring for atrioventricular valve reconstruction. Ann Thorac Surg 1976; 22:458-463) introduced a completely circumferential flexible ring in 1976. In 1995, Cosgrove et al (Cosgrove D M III, et al, Initial experience with the Cosgrove-Edwards annuloplasty system. Ann Thorac Surg 1995; 60:499-504) introduced a partially circumferential flexible band attached only to the posterior mitral leaflet of the annulus. In the same year, Carpentier et al. (Carpentier, A F, et al. The “Physio-Ring”: An advanced concept in mitral valve annuloplasty. Ann Thorac Surg 1995; 60:1177-1186) introduced the “Physio-Ring,” i.e. a complete ring with a “combination of selective rigidity at the anterior section and selective flexibility at the posterior section.
The short- and long-term results of mitral repair are impressive. It appears to be the only heart valve operation which has the potential to return patients to expected survival at least for 10 years, and possibly longer, if performed before significant left ventricular dysfunction and symptoms. It has a lower operative mortality rate and better long-term survival than replacement and has long-term re-operation rates comparable to those of mechanical valve replacement, and much better than tissue valve replacement. The durability of repair is impressive as evidenced by the very low long-term re-operation rates in Carpentier's original series.
It is quite possible that an annuloplasty ring with overall flexibility and segmental rigidity, which preserves the normal three-dimensional shape of the annulus, prevents crimping upon implantation, maximizes apposition of the ring to the tissue annulus with each individual suture, minimizes shared tensions between individual sutures and (in the case of the mitral annulus) fully engages the intertrigonal fibrous skeleton, will qualify as a “next generation” ring.
In 1998, Northrup and al introduced the concept of a suture-platform, which forms the basis of the “Northrup Universal Annuloplasty System”. When the suture-platforms were placed in series and covered with a flexible material, a unique annuloplasty concept with segmental rigidity and overall flexibility was achieved.
In the case of the suture-platform, foreshortening or crimping of the overlying flexible ring material is impossible because each mattress suture engages an individual rigid suture-platform within the mattress suture loop.
In U.S. Pat. No. 5,961,539 is disclosed an annuloplasty ring which consists in a plurality of discrete segments which remain isolated from each other, even after having been sutured. Each segment rests on an individual holder.
This ring is suitable for the annuloplasty of said mitral and tricuspid valves. But it can also be used with other valves, for example aortic and pulmonary valves.
Another type of known ring is made, for example, with fifteen implantable rigid oval-platforms in sequence, plus two ending suture platforms. Two of these platforms are visible on FIG. 5 of the present application.
The length d1 of each platform 40 is 5.5 mm±1 mm, with two suture holes 42, approximately 3.0 mm apart (d2) in sequence.
They are linked by a joint 41, whose length d3 is approximately 2 mm.
Such platforms 40 and joints 41 are integral and preferably injection-molded from polyester, including 20% of barium sulphate for radio-opacity.
As can be seen in FIG. 6 of this application, polyester thread 43 is braided over the platforms 40, leaving flexible joints 41 between said platforms. The joints are heat-sealed to prevent fraying of the polyester thread when unused suture-platforms are cut away.
Because the rigidity of the ring 4 is segmental and not continuous, with intervening segmental flexibility at the joints 41, the ring is able to maintain its normal three-dimensional shape. The rigidity of the suture-platforms 40 also guarantees either a measured plication or stabilization of annular tissue beneath the suture-platform with a mattress suture.
The rigid suture-platforms 40 categorically prevent any crimping or foreshortening of the longitudinal dimension of the ring 4, since each suture incorporates a single separate non-deformable rigid element (i.e. a platform 40), guaranteeing precision of the final implant dimension. Since the polyester braiding has almost no elasticity, the ring 4 also guarantees a fixed maximum circumference, preventing late annular dilatation in whatever portion of the annulus the ring is attached.
The overall 7.5 mm. interval spacing of the suture-platforms 40 guarantees secure apposition of the ring 4 to the tissue annulus, since nearly 75% of the circumferential length of the annuloplasty ring 4 consists of the sum total of all the suture-platforms 40, each of which engages the tissue annulus by an individual mattress suture.
The implantable length of the ring is 112.5 mm, long enough to accommodate valves of any size, even if complete circumferential coverage of the annulus is required.
The heat-sealed joints 41 create overall flexibility and allow the ring 4 to be customized to any size to cover any percentage circumference of the mitral or tricuspid annulus, by simply cutting away the unwanted suture-platforms 40.
Flexible joints 41 also reduce overall tension on each of the individual sutures by reducing any shared tension from other sutures, which would be the case with any rigid ring possessing continuous rigidity and forcing the annulus into a prescribed shape.
Nevertheless, because of the flexibility of the ring, a great dexterity is needed to implant it, without any help.
So there exists a need for a support for this type of ring which could help the surgeon for its implantation in an annuloplasty surgery.
Another need exists for a support than can be used whatever the final number of platforms which will be implanted.